Behavioral Intervention Trial for HIV-infected Injection Drug Users

This study has been completed.

Sponsor:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00146445

First Posted: September 7, 2005

Last Update Posted: September 27, 2012

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The purpose of this study is to test whether a ten-session behavioral intervention for HIV-infected injection drug users is effective in reducing sex and injection risk behaviors that put others at risk for HIV infection, increasing access to or utilization of HIV primary health care, and increasing adherence to HIV medications.

- lending needle or sharing cotton, cooker, or rinse water with HIV-negative or unknown serostatus partners in the past 3 months

-health care visits for HIV primary care in the past 6 months

-90% or more adherence to HIV medication yesterday and in the past week

Secondary Outcome Measures:

-Proportion of HIV status disclosure to sex partners

Estimated Enrollment:

1000

Study Start Date:

August 2001

Study Completion Date:

July 2006

Primary Completion Date:

July 2006 (Final data collection date for primary outcome measure)

Detailed Description:

INSPIRE is a four-site (Baltimore, Miami, New York and San Francisco) randomized control trial to develop and evaluate the efficacy of a ten-session intervention for HIV-positive injection drug users. The primary goals of the intervention are to:

The intervention arm consists of 7 group sessions, 2 individual sessions, and one community experience. The control arm consists of 8 group sessions, aiming at controlling for demand (1st session) and attention (8 group sessions). Behavioral assessments and blood draws (for viral load and CD4 testing) occur at baseline, 6, and 12 month follow-up; a 3 month assessment involves behavioral assessment only. 1161 participants took baseline. Of these, 966 were randomized into the study, and 840, 807, and 821 participants took 3, 6, and 12 month follow-up assessments, respectively.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

18 years of age or older

self-identify as a person who has injected drugs in the last 12 months

self-identify as a person who has had sex with at least one opposite sex partner within the last 3 months